BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYSTO-NEPHRO VIDEOSCOPE

    MDR report key: 20990892 · Received December 20, 2024

    Report

    Report Number
    3002808148-2024-39062
    Event Type
    Malfunction
    Date Received
    December 20, 2024
    Date of Event
    November 20, 2024
    Report Date
    December 20, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FAJ
    PMA / PMN Number
    K221683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE RESULTS OF THE INVESTIGATION, THE CAUSE OF THE DISTAL END DETACHMENT WAS UNABLE TO BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED DETACHMENT OF THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT. 2 LEAK TEST REQUIRED BENDING RUBBER IS LEAKING. 3 C-COVER INSL REQUIRED C-COVER FAILED INSULATION TEST. 5 A-RUBBER REQUIRED BENDING RUBBER IS DAMAGED. 15 BENDING SECTION REQUIRED DISTAL END IS DETACHED. 16 INSERTION TUBE RECOMMEND INSERTION TUBE HAS SCRATCH MARKS. INFORMATION TAKEN FROM QIR IN UPDATE REQUESTUR-000182. MCB/496056/28-OCT-2024. DUE DILIGENCE DD-024789. ANY (SUSPECTED) PATIENT INFECTION? AND CULTURE TEST POSITIVE FIELDS HAS BEEN UPDATED ACCORDING TO THE INFORMATION RECEIVED IN THE DUE DILIGENCE DD-024789. MCB/496056/28-OCT-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2164897 CYSTO-NEPHRO VIDEOSCOPE CYSTO-NEPHRO VIDEOSCOPE FAJ AIZU OLYMPUS CO., LTD. CYF-VH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown